Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides

Renal Cell Cancer Clinical Trial

— UroRCC  

Official title:

Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02429440
• Other study ID #: 231/2004
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: April 14, 2015
• Last updated: August 14, 2017
• Start date: May 2005
• Est. completion date: June 2018

Study information

• Verified date: August 2017
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer (RCC).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced renal cell carcinoma clinical stage T3 or T4, N0, M0

• N+, M0

• M1 (after complete metastasectomy)

• ECOG performance status 0 or 1

• age >18 years

• at least 4 weeks since last administration of radiation- or chemotherapy

• Serum levels of bilirubin <2 mg/dl, creatinine<2mg/dl

Exclusion Criteria:

• detectable distant metastasis in radiological imaging (M1)

• patients unable to consent

• severe cardiopulmonary disorder (NYHA >= 3)

• presence of secondary malignancy

• Immunosuppressive medication (last application of glucocorticoids > 4 weeks)

• seizure

• pregnancy

• simultaneous participation in other active or passive immunisation treatment

Related Conditions & MeSH terms

• Advanced Renal Cell Cancer
• Carcinoma, Renal Cell
• Renal Cell Cancer

Intervention

Biological:
• peptide vaccine
subcutaneous

Drug:
• Granulocyte Macrophage Colony Stimulating Factor
intradermal
• Montanide ISA-51
subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability	Tolerability, as measured by number of Participants with Adverse Events	Day 0-365
Secondary	All Cause Mortality	All cause Mortality, as measured as length of Overall Survival	60 Months
Secondary	Progression-free Survival	Progression-free Survival, as measured as time to radiographic progression	36 Months
Secondary	Immune Response	Immune Response, as as measured by in vitro and in vivo T cell response on day 0 and day 70. In selected cases additional immune response evaluation might be applicable.	Day 0-365